Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

• Sponsor: Curis, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02307240
• Collaborator: (none)
• Enrollment: 43
• Locations: 4
• Arm: 1
• Duration (Months): 54.9
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Triple-Negative Breast Cancer; High-grade Serous Ovarian Cancer; Solid Tumors; NUT Midline Carcinoma	Drug: CUDC-907	Phase 1

Detailed Description

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:

Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CUDC-907 - five days on/two days off 60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met.	Drug: CUDC-907; CUDC-907 oral with meals.

Outcome Measures

Primary Outcome Measures

1. To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors [21 day cycle]

Secondary Outcome Measures

1. To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC). [21 day cycle]

2. To evaluate biomarkers of CUDC-907 activity [24 months]

3. To assess the preliminary anti-cancer activity of CUDC-907 [24 months]

   The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.

2. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.

3. Measurable or evaluable disease.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).

Exclusion Criteria:

1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.

2. Radiotherapy within one week prior to starting study treatment.

3. Other investigational agent(s) within 21 days prior starting to study treatment.

4. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.

5. Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF School of Medicine	San Francisco	California	United States	94143
2	Florida Cancer Specialists	Sarasota	Florida	United States	34232
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Curis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Curis, Inc.
• ClinicalTrials.gov Identifier: NCT02307240
• Other Study ID Numbers: CUDC-907-102
• First Posted: Dec 4, 2014
• Last Update Posted: Sep 3, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Curis, Inc.: TNBC; HGSOC; NMC
• Additional relevant MeSH terms: Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Sep 3, 2019